Safety & Immunogenicity Study of Meningococcal Vaccine GSK134612 Given With Priorix-Tetra™ to 12-23 Month-Old Children

• Meningococcal rSBA titres [ Time Frame: 42 days after the first vaccine dose ] [ Designated as safety issue: No ]
• Anti-measles seroconversion [ Time Frame: 42 days after the first vaccine dose ] [ Designated as safety issue: No ]
• Anti-mumps seroconversion [ Time Frame: 42 days after the first vaccine dose ] [ Designated as safety issue: No ]
• Anti-rubella seroconversion [ Time Frame: 42 days after the first vaccine dose ] [ Designated as safety issue: No ]
• Anti-varicella seroconversion [ Time Frame: 42 days after the first vaccine dose ] [ Designated as safety issue: No ]

• Meningococcal rSBA titres [ Time Frame: Prior to and 42 days after the first vaccine dose ] [ Designated as safety issue: No ]
• Anti-meningococcal polysaccharide concentrations [ Time Frame: Prior to and 42 days after the first vaccine dose ] [ Designated as safety issue: No ]
• Anti-measles concentrations [ Time Frame: 42 days after the first vaccine dose, in all groups, and 42 days after the second Priorix-Tetra™ vaccine dose, in a subset (30%) of Groups A and C only ] [ Designated as safety issue: No ]
• Anti-mumps concentrations [ Time Frame: 42 days after the first vaccine dose, in all groups, and 42 days after the second Priorix-Tetra™ vaccine dose, in a subset (30%) of Groups A and C only ] [ Designated as safety issue: No ]
• Anti-rubella concentrations [ Time Frame: 42 days after the first vaccine dose, in all groups, and 42 days after the second Priorix-Tetra™ vaccine dose, in a subset (30%) of Groups A and C only ] [ Designated as safety issue: No ]
• Anti-varicella titres [ Time Frame: 42 days after the first vaccine dose, in all groups, and 42 days after the second Priorix-Tetra™ vaccine dose, in a subset (30%) of Groups A and C only ] [ Designated as safety issue: No ]
• Occurrence of solicited local and general symptoms [ Time Frame: During the 4-day follow-up period after the first vaccine dose ] [ Designated as safety issue: Yes ]
• Occurrence of general symptoms specific for MMR and varicella vaccination (Priorix-Tetra™) [ Time Frame: During the 43-day follow-up period after the first vaccine dose ] [ Designated as safety issue: Yes ]
• Occurrence of unsolicited symptoms [ Time Frame: During the 43-day follow-up period after the first vaccine dose ] [ Designated as safety issue: Yes ]
• Occurrence of serious adverse events [ Time Frame: Throughout the whole study duration (from Day 0 up to Month 6) ] [ Designated as safety issue: Yes ]
• Occurrence of specific adverse events of rash, new onset of chronic illness(es) and conditions prompting emergency room visits and physician office visits not related to common illnesses [ Time Frame: Throughout the whole study duration (from Day 0 up to Month 6) ] [ Designated as safety issue: Yes ]

• 42 days post second Priorix-Tetra dosing: immunogenicity to vaccine antigens
• Solicited and unsolicited AEs post dose 1 (up to d 42).
• SAEs throughout study

The purpose of this study is to demonstrate, in 12-23 month old children, the non-inferiority of the meningococcal vaccine 134612 given with Priorix-Tetra™.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Open multicentre study with 4 treatment groups. Two groups will receive the 134612 vaccine with Priorix-Tetra™ either at the same or different visits followed by a second Priorix-Tetra™ vaccination at 84 days.

Two control groups will receive Priorix-Tetra™ and Meningitec™ at different visits followed by a second Priorix-Tetra™ vaccination at 84 days.

For all subjects, two blood samples will be taken: prior to and 42 days after the first vaccination. In a subset (30% of subjects in Groups A en C) from selected study centres: additional sample 42 days after second Priorix-Tetra™ dose.

• Rubella
• Meningococcal Serogroup A, C, W-135, Y Diseases
• Varicella
• Mumps
• Measles

• Biological: Meningococcal vaccine GSK134612
  Single dose intramuscular injection
• Biological: Priorix-Tetra™
  2-dose subcutaneous injection
• Biological: Meningitec™
  Single dose intramuscular injection

• Experimental: Group A
  Meningococcal vaccine GSK134612 + Priorix-Tetra™, followed by the second dose of Priorix-Tetra™ 84 days later
  Interventions:

  • Biological: Meningococcal vaccine GSK134612
  • Biological: Priorix-Tetra™
• Experimental: Group B
  Meningococcal vaccine GSK134612, followed by 2 doses of Priorix-Tetra™, respectively 42 and 84 days later
  Interventions:

  • Biological: Meningococcal vaccine GSK134612
  • Biological: Priorix-Tetra™
• Active Comparator: Group C
  Priorix-Tetra™, followed by Meningitec™ 42 days later and the second dose of Priorix-Tetra™ 84 days later
  Interventions:

  • Biological: Priorix-Tetra™
  • Biological: Meningitec™
• Active Comparator: Group D
  Meningitec™, followed by 2 doses of Priorix-Tetra™, respectively 42 and 84 days later
  Interventions:

  • Biological: Priorix-Tetra™
  • Biological: Meningitec™

Inclusion Criteria:

• Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
• A male or female between, and including, 12 and 23 months of age at the time of the vaccination.
• Written informed consent obtained from the parent or guardian of the subject.
• Free of obvious health problems as established by medical history and clinical examination before entering into the study.
• Previously completed routine childhood vaccinations to the best of parents' or legal guardians' knowledge.

Exclusion Criteria:

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose.
• Planned administration/ administration of a vaccine not foreseen by the study protocol within one month before and 42 days after the first dose of vaccine(s).
• Previous vaccination with meningococcal vaccine of serogroup A, C W and/or Y.
• History of meningococcal disease.
• Previous vaccination against measles, mumps, rubella, and/or varicella.
• History of measles, mumps, rubella and/or varicella.
• Known exposure to measles, mumps, rubella, varicella or zoster within 30 days prior to vaccination.
• Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, including neomycin.
• Major congenital defects or serious chronic illness.
• Acute disease at the time of enrolment.
• Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.